Month: January 2018

Nevada Issues Regulations and Guidance Related to Pharmaceutical Manufacturer Transparency Reporting Requirements

The Nevada Department of Health and Human Services (Department) recently released draft regulations implementing SB 539, which was signed into law in June 2017. The regulations require drug manufacturers and pharmacy benefits managers to submit a report in the format listed on the Department website by April 1st for the […]

New Jersey Adopts Regulations Targeting Gifts and Payments from Pharmaceutical Manufacturers to Prescribers

Regulations adopted by the New Jersey Attorney General Division of Consumer Affairs titled LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS became effective last week. These Regulations provide the rules under which prescribers may receive anything of value from pharmaceutical and biologics manufacturers. ‘Prescribers’ is defined […]

OIG Permits Drug Companies To Provide Free Medications in Limited Circumstances to Patients for 2018 Following Advisory Opinion Rescission

As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that the PAP failed to fully, completely and accurately disclose all relevant and material facts to the OIG and failed […]